deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT05108922

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease

Sponsor: Eli Lilly and Company

Conditions Alzheimer Disease Mild Cognitive Impairment (MCI)
Interventions Aducanumab Donanemab
Updated 18 times since 2021 Last updated: Nov 4, 2024 Started: Nov 16, 2021 Primary completion: Sep 9, 2022 Completion: Sep 19, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Alzheimer Disease and Mild Cognitive Impairment (MCI) and is currently completed. Eli Lilly and Company leads this study, which shows 18 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Aug 2023 · 6 months · monthly snapshot~Aug 2023 – ~Dec 2023 · 4 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – present · 20 months · monthly snapshot

Change History

18 versions recorded

  1. Dec 2024 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Dec 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Aug 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE3

▶ Show 13 earlier versions

  1. Feb 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  6. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  8. May 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  10. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  11. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  12. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  13. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eli Lilly and Company
Data source: Eli Lilly and Company

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Abington, United States , Atlantis, United States , Chesterfield, United States , Columbus, United States , Dallas, United States , Dayton, United States , Delray Beach, United States , Fort Myers, United States , Fullerton, United States , Hollywood, United States and 20 more locations